Study of Denosumab vs. Zoledronic Acid to Treat Bone Metastases in Men With Hormone-refractory Prostate Cancer
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| ClinicalTrials.gov Identifier: NCT00321620 |
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Recruitment Status :
Completed
First Posted : May 4, 2006
Results First Posted : March 21, 2014
Last Update Posted : August 29, 2018
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Sponsor:
Amgen
Information provided by (Responsible Party):
Amgen
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Brief Summary:
The purpose of this study is to determine if denosumab is non-inferior to zoledronic acid (Zometa®) in the treatment of bone metastases in men with hormone-refractory prostate cancer
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Bone Metastases | Drug: zoledronic acid Biological: denosumab | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 1904 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Supportive Care |
| Official Title: | A Randomized, Double-Blind, Multicenter Study of Denosumab Compared With Zoledronic Acid (Zometa®) in the Treatment of Bone Metastases in Men With Hormone-Refractory Prostate Cancer |
| Actual Study Start Date : | April 1, 2006 |
| Actual Primary Completion Date : | October 1, 2009 |
| Actual Study Completion Date : | February 24, 2012 |
Resource links provided by the National Library of Medicine
Genetics Home Reference related topics:
Prostate cancer
| Arm | Intervention/treatment |
|---|---|
| Active Comparator: zoledronic acid |
Drug: zoledronic acid
Q4W 4 mg zoledronic acid IV over minimum 15 minutes and 120 mg denosumab placebo SC
Other Name: Zometa |
| Experimental: denosumab |
Biological: denosumab
Q4W 120 mg denosumab SC and 4 mg zoledronic acid placebo IV over a minimum of 15 minutes |
Primary Outcome Measures :
- Time to the First On-Study SRE (Non-inferiority) [ Time Frame: Up to 40.5 months ]Time to the first on-study skeletal-related event (SRE) analyzed for non-inferiority. Kaplan-Meier estimates of the median and its dispersion are reported.
Secondary Outcome Measures :
- Time to the First On-Study SRE (Superiority) [ Time Frame: Up to 40.5 months ]Time to the first on-study skeletal-related event (SRE), analyzed for superiority of denosumab. Kaplan-Meier estimates of the median and its dispersion are reported.
- Time to the First-And-Subsequent On-Study SRE [ Time Frame: Up to 40.5 months ]
Time to the first-and-subsequent on-study skeletal-related event (SRE), analyzed for superiority of denosumab using multiple event analysis, the event must occur at least 21 days after the previous SRE.
This outcome measure utilizes multiple event times, was analyzed based on a proportional mean model, and is therefore more appropriately summarized by the cumulative mean number of events.
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Men >/= 18 years of age with histologically confirmed prostate cancer
- Radiographic evidence of at least one bone metastasis
- Failure of at least one hormonal therapy as evidenced by a rising PSA
- Serum testosterone level of <50 ng/dL
- ECOG PS 0, 1, or 2
- Adequate organ function
Exclusion Criteria:
- Current or prior IV bisphosphonate administration
- Current or prior oral bisphosphonates for bone mets
- Life expectancy of less than 6 months
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00321620
Sponsors and Collaborators
Amgen
Investigators
| Study Director: | MD | Amgen |
Additional Information:
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Amgen |
| ClinicalTrials.gov Identifier: | NCT00321620 History of Changes |
| Other Study ID Numbers: |
20050103 |
| First Posted: | May 4, 2006 Key Record Dates |
| Results First Posted: | March 21, 2014 |
| Last Update Posted: | August 29, 2018 |
| Last Verified: | August 2018 |
Keywords provided by Amgen:
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Bone metastases Hormone-refractory prostate cancer Skeletal |
Fractures Compressions Bisphosphonates |
Additional relevant MeSH terms:
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Prostatic Neoplasms Neoplasm Metastasis Neoplasms, Second Primary Bone Neoplasms Bone Marrow Diseases Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site Neoplasms Genital Diseases, Male Prostatic Diseases |
Neoplastic Processes Pathologic Processes Bone Diseases Musculoskeletal Diseases Hematologic Diseases Zoledronic Acid Denosumab Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Bone Density Conservation Agents |